Regulatory Affairs Manager (m/f/d) - Sustaining

OLYMPUS EUROPA SE & CO. KG; Teltow, Hamburg; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

A leading company in medical technology is seeking a Regulatory Affairs Manager to coordinate sustaining activities. This role involves managing change, CAPA activities, and mentoring colleagues, making it pivotal in ensuring compliance and process improvement. The ideal candidate will have extensive experience in the medical device industry and a strong educational background in engineering.

Leistungen

30 days of annual leave

Up to 60% mobile work possible

Holiday and Christmas bonuses

Corporate benefits discounts

Comprehensive pension scheme

Subsidized healthy food at the company restaurant

Employee Assistance Program

Subsidies for public transportation

Free parking

Subsidized sports groups and activities

Qualifikationen

• 5+ years of experience in regulatory affairs within the medical device industry.
• Strong knowledge of global regulatory frameworks and requirements.
• Experience supporting lifecycle management activities.

Aufgaben

• Coordinate sustaining activities within Regulatory Affairs.
• Mentor and train RA colleagues on HHA, CAPA, and product change processes.
• Drive continuous improvement of RA processes.

Kenntnisse

Knowledge of global regulatory frameworks

Change management

Interpersonal skills

Communication skills

Ausbildung

Bachelor’s, Diploma, or Master’s degree in Engineering

Jobbeschreibung

Regulatory Affairs Manager (m/f/d) - Sustaining

Olympus Winter & Ibe GmbH (OWI) is a high-tech specialist within the Olympus Corporation, focusing on the development and manufacturing of rigid endoscopy, bipolar high-frequency surgery, and reprocessing. With approximately 2,600 employees across nine locations in EMEA and headquartered in Hamburg, the company is recognized for exceptional performance in medical diagnostics and therapy, offering a comprehensive range of modern endoscopic applications, from individual products to procedure-oriented system solutions.

Your Responsibilities

1. Coordinate sustaining activities within Regulatory Affairs (RA), including change management, CAPA (Corrective and Preventive Actions), and Health Hazard Assessment (HHA).
2. Represent RA in HHA-related meetings and CAPA boards.
3. Serve as RA Subject Matter Expert (SME) for sustaining activities involving operational work in product changes, CAPAs, and HHAs.
4. Act as the primary RA contact for interactions with local HHA, CAPA, and product change teams regarding operational and process-related matters.
5. Mentor and train RA colleagues on HHA, CAPA, and product change processes.
6. Drive continuous improvement of RA processes related to product lifecycle activities.

Your Qualifications

• Bachelor’s, Diploma, or Master’s degree in Engineering or a related field (or equivalent experience).
• 5+ years of experience in regulatory affairs within the medical device industry.
• Strong knowledge of global regulatory frameworks and requirements.
• Experience supporting lifecycle management activities, including change management, CAPAs, and Health Hazard Assessments.
• Intrinsic understanding of QMS processes/systems and experience in process development.
• Excellent interpersonal skills for managing cross-functional relationships and explaining complex regulatory concepts to non-regulatory stakeholders and junior team members.
• Proficiency in English communication; German skills are beneficial.

Your Benefits

• 30 days of annual leave.
• Up to 60% mobile work possible with flexible working hours and overtime compensation.
• Holiday and Christmas bonuses.
• Corporate benefits discounts.
• Comprehensive pension scheme and capital-forming benefits.
• Subsidized healthy food at the company restaurant.
• Employee Assistance Program supporting health and well-being.
• Subsidies for public transportation, free parking, and leasing options.
• Subsidized sports groups and activities.

About Olympus

Olympus is committed to making people’s lives healthier, safer, and more fulfilling. As a global leader in medical technology, we collaborate with healthcare professionals to provide solutions that improve patient outcomes through early detection, diagnosis, and minimally invasive treatments. With over 100 years of history, Olympus strives to contribute to society by delivering innovative products designed for optimal outcomes.

For more information, visit www.olympus-europa.com and follow us on LinkedIn: linkedin.com/company/OlympusMedEMEA.

Further Information

We value diversity and are committed to an inclusive, non-discriminatory workplace where everyone feels a sense of belonging. We encourage all talented individuals to apply and join our team.